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Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012-2017
Lauren A Beste1, Michael Icardi1, Christine M Hunt1
1From the General Medicine Service (Dr Beste) and Health Services Research and Development (Drs Beste, Lowy, and Taylor, and Ms Gylys-Colwell), VA Puget Sound Health Care System, Seattle, Washington; General Internal Medicine, University of Washington School of Medicine, Seattle (Dr Beste); Pathology Service, VA Iowa City, Iowa City (Dr Icardi); Pathology Department, University of Iowa Carver College of Medicine, Iowa City (Dr Icardi); Cooperative Studies Program Epidemiology Center, Durham VA Health Care System, Durham, North Carolina (Dr Hunt); Gastroenterology Service, Duke University Medical Center, Durham, North Carolina (Dr Hunt); Department of Health Services, University of Washington School of Public Health, Seattle (Dr Lowy); Medical Service, VA Long Beach Healthcare System, Long Beach, California (Dr Morgan); Gastroenterology Section, University of California, Irvine (Dr Morgan); Medical Service, VA Portland Health Care System, Portland, Oregon (Drs Chang and Maier); Gastroenterology Service (Dr Chang) and Infectious Diseases Service (Dr Maier), Oregon Health and Sciences University School of Medicine, Portland; the Department of Medicine (Gastroenterology and Hepatology), VA Palo Alto Health Care System, Palo Alto, California (Dr Cheung); and Medical Service (Gastroenterology and Hepatology), Stanford University, Palo Alto, California (Dr Cheung).
Context.—:
Disease guidelines specify universal alanine aminotransferase (ALT) thresholds for clinical decision-making, yet the effect of variability among ALT analyzers remains unclear.
Objective.—:
To compare ALT results from different analyzers from 2012-2017.
Design.—:
Veterans Health Administration (VHA) laboratories perform external ALT proficiency testing using standardized College of American Pathologists (CAP) samples in analyzers by 5 manufacturers. In this operational analysis, we evaluated 22 950 ALT values from 80 independent CAP samples tested at 223 laboratories. Using mixed effects modeling, we estimated the association between analyzer manufacturer and CAP outcome, adjusting for manufacturer, facility, and calendar year. We performed subgroup analyses on CAP samples with overall means near clinical guideline-specified thresholds, including less than 50 U/L (n = 10) and less than 35 U/L (n = 5).
Results.—:
The VHA used Abbott Laboratories (n = 3175; 14%), Beckman Coulter Diagnostics (n = 8723; 38%), Roche Diagnostics (n = 2595; 11%), Siemens Healthineers USA (n = 5713; 25%), and Vitros/Ortho Clinical Diagnostics (n = 2744; 12%) analyzers. The CAP samples (n = 80 samples, n = 22 950 tests) covered a wide range of mean ALT values (21-268 U/L). The average difference in mean ALT value per sample between the highest-reading and lowest-reading manufacturers was 15.4 U/L (SD = 1.8) for the 10 samples with mean ALT less than 50 U/L, and it was 10.4 U/L (SD = 3.6) overall (n = 80). In linear mixed effects modeling, we found statistically significant differences in ALT values between the different manufacturers in each year.
Conclusions.—:
We found statistically and clinically meaningful differences between analyzers across the ALT spectrum in each year, including at ALT levels lower than 50 U/L and lower than 35 U/L. Universal ALT thresholds should be avoided as a trigger for clinical action until differences between analyzers can be resolved.
